EP 4249060 A2 20230927 - LIQUID PHARMACEUTICAL COMPOSITION OF ADALIMUMAB
Title (en)
LIQUID PHARMACEUTICAL COMPOSITION OF ADALIMUMAB
Title (de)
FLÜSSIGE PHARMAZEUTISCHE ZUSAMMENSETZUNG VON ADALIMUMAB
Title (fr)
COMPOSITION PHARMACEUTIQUE LIQUIDE DE L'ADALIMUMAB
Publication
Application
Priority
- EP 14169754 A 20140523
- EP 19215036 A 20150515
- EP 18169979 A 20150515
- EP 15724974 A 20150515
- EP 2015060817 W 20150515
Abstract (en)
The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, an histidine buffering agent such as histidine (or histidine buffer system such as histidine/imidiazoliumhistidine), and a disaccharide sugar stabiliser. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. prefilled syringes) to reduce unnecessary waste of the drug.
IPC 8 full level
A61P 29/00 (2006.01)
CPC (source: CN DK EP IL US)
A61K 9/00 (2013.01 - DK IL); A61K 9/0019 (2013.01 - CN EP IL US); A61K 9/08 (2013.01 - CN IL); A61K 38/00 (2013.01 - DK IL); A61K 39/39591 (2013.01 - CN EP IL US); A61K 47/02 (2013.01 - EP IL); A61K 47/183 (2013.01 - CN EP IL US); A61K 47/26 (2013.01 - CN DK EP IL US); A61P 1/00 (2018.01 - EP IL); A61P 1/04 (2018.01 - EP IL); A61P 7/00 (2018.01 - EP IL); A61P 17/06 (2018.01 - EP IL); A61P 19/00 (2018.01 - EP IL); A61P 19/02 (2018.01 - EP IL); A61P 19/08 (2018.01 - EP IL); A61P 27/14 (2018.01 - EP IL); A61P 29/00 (2018.01 - EP IL); A61P 37/06 (2018.01 - EP IL); C07K 16/241 (2013.01 - CN EP IL US); C07K 2317/21 (2013.01 - CN EP IL US); C07K 2317/76 (2013.01 - CN EP IL US)
Citation (applicant)
- WO 9729131 A1 19970814 - BASF AG [DE], et al
- PENNICA, D ET AL., NATURE, vol. 312, 1984, pages 724 - 729
- DAVIS, J. M ET AL., BIOCHEMISTRY 26, 1987, pages 1322 - 1326
- JONES, E. Y ET AL., NATURE, vol. 338, 1989, pages 225 - 228
Designated contracting state (EPC)
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
DOCDB simple family (publication)
EP 2946766 A1 20151125; EP 2946766 B1 20160302; AU 2015263246 A1 20161117; AU 2015263246 B2 20180621; AU 2018222887 A1 20180913; AU 2018222887 B2 20200227; AU 2020201090 A1 20200305; AU 2020201090 B2 20220310; AU 2022203863 A1 20220623; CA 2947487 A1 20151126; CA 2947487 C 20190924; CA 3050875 A1 20151126; CN 106659781 A 20170510; CN 108785670 A 20181113; CY 1120488 T1 20190710; DE 23189888 T1 20240321; DK 201800070 U1 20180918; DK 201800070 Y4 20181213; DK 201800070 Y8 20190709; DK 201800071 U1 20181205; DK 201800071 Y4 20181213; DK 3148510 T3 20180716; EP 3148510 A1 20170405; EP 3148510 B1 20180627; EP 3403646 A1 20181121; EP 3403646 B1 20220928; EP 3659582 A1 20200603; EP 3659582 B1 20230816; EP 4249060 A2 20230927; EP 4249060 A3 20240103; ES 2572919 T3 20160603; ES 2683194 T3 20180925; ES 2928738 T3 20221122; ES 2955316 T3 20231130; HK 1257026 A1 20191011; HR P20181226 T1 20181019; HU E040097 T2 20190228; IL 249117 A0 20170131; IL 249117 B1 20240701; IL 249117 B2 20241101; JP 2017516847 A 20170622; JP 2020033361 A 20200305; JP 2022003091 A 20220111; JP 6962984 B2 20211105; LT 3148510 T 20181010; PL 3148510 T3 20181130; PT 3148510 T 20180928; RS 57772 B1 20181231; SI 3148510 T1 20181030; US 10493152 B2 20191203; US 10772961 B2 20200915; US 11752208 B2 20230912; US 11752209 B2 20230912; US 12109267 B2 20241008; US 2017189527 A1 20170706; US 2020085948 A1 20200319; US 2021023215 A1 20210128; US 2023061801 A1 20230302; US 2023338527 A1 20231026; WO 2015177058 A1 20151126
DOCDB simple family (application)
EP 14169754 A 20140523; AU 2015263246 A 20150515; AU 2018222887 A 20180827; AU 2020201090 A 20200214; AU 2022203863 A 20220603; CA 2947487 A 20150515; CA 3050875 A 20150515; CN 201580039868 A 20150515; CN 201810768437 A 20150515; CY 181100812 T 20180806; DE 23189888 T 20150515; DK 15724974 T 20150515; DK BA201800070 U 20180907; DK BA201800071 U 20180907; EP 15724974 A 20150515; EP 18169979 A 20150515; EP 19215036 A 20150515; EP 2015060817 W 20150515; EP 23189888 A 20150515; ES 14169754 T 20140523; ES 15724974 T 20150515; ES 18169979 T 20150515; ES 19215036 T 20150515; HK 18116149 A 20181217; HR P20181226 T 20180801; HU E15724974 A 20150515; IL 24911716 A 20161122; JP 2017513323 A 20150515; JP 2019187090 A 20191010; JP 2021167297 A 20211012; LT 15724974 T 20150515; PL 15724974 T 20150515; PT 15724974 T 20150515; RS P20180919 A 20150515; SI 201530341 T 20150515; US 201515313480 A 20150515; US 201916694627 A 20191125; US 202016990954 A 20200811; US 202217979272 A 20221102; US 202217979309 A 20221102